PESTICIDE SAFETY

Improvements 

Needed in EPA’s 

Good Laboratory 

Practices Inspection 

Program

Report to the Ranking Member, 

Subcommittee on Environment and the 

Economy, Committee on Energy and 

Commerce, House of Representatives

May 2014

GAO-14-289

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-14-289, a report to the 

Ranking Member, Subcommittee on 

Environment and the Economy, Committee on 

Energy and Commerce, House of 

Representatives

May 2014

PESTICIDE SAFETY

Improvements Needed in EPA’s Good Laboratory 

Practices Inspection Program

Why GAO Did This Study

Pesticides used to control weeds, 

unwanted insects, and fungi contribute 

to agricultural productivity and public 

health by preventing crop damage and 

controlling pests. However, pesticides 

may also have adverse effects. EPA’s 

OPP reviews applications for pesticide 

products and registers those that it 

determines do not have unreasonable 

adverse effects on health and the

environment. EPA’s OECA inspects 

laboratories where these pesticides are 

tested to ensure that the laboratories 

followed EPA’s GLP regulations. FDA 

also conducts GLP laboratory 

inspections. GAO was asked to review 

EPA’s GLP Compliance Monitoring 

Program. This report examines the 

extent to which EPA (1) inspects for 

GLP compliance laboratories that test 

pesticides and the challenges EPA 

faces in doing so, (2) uses the 

information obtained through GLP 

inspections in its pesticide decisionmaking process, and (3) collaborates 

with FDA on GLP inspections. To 

conduct this work, GAO reviewed 

relevant agency documents and data, 

conducted a nongeneralizeable survey 

of 20 laboratories, and interviewed 

EPA and FDA officials and laboratory 

and other stakeholders.

What GAO Recommends

GAO recommends, among other 

things, that EPA assess its authority 

and need for a fee-based inspection 

system for the GLP Program, 

determine why the database 

information to prioritize laboratories is 

incomplete, and that EPA and FDA 

develop a process to collaborate and 

share information on planned and 

completed inspections. EPA and FDA 

agreed with GAO’s recommendations.

What GAO Found

The Environmental Protection Agency (EPA) inspects few laboratories that test 

pesticides for Good Laboratory Practices (GLP) compliance and faces 

challenges in selecting laboratories to inspect. For fiscal years 2009 to 2013, 

EPA’s Office of Enforcement and Compliance Assurance (OECA) GLP 

Compliance Monitoring Program inspected from 51 to 80 laboratories annually 

from an estimated 1,400 that conducted studies used to support applications for 

pesticide registrations. During the same period, EPA reduced OECA’s GLP 

Compliance Program budget and staff by about half. Laboratory and other 

stakeholders told GAO that not having GLP inspections can negatively affect a 

laboratory’s business domestically and abroad. OECA prioritizes laboratories for 

GLP inspections using criteria that reflect, among other things, how long it has 

been since the last inspection and the number of studies the laboratory has 

conducted that have been submitted to EPA’s Office of Pesticide Programs 

(OPP) in support of a pesticide registration application. However, GAO found that 

some laboratory information in the OECA database used to prioritize inspections 

was either inaccurate or incomplete, making it difficult to target laboratories for 

inspections. GAO also found that OECA is considering ways the GLP program 

could be run more efficiently given its recent budget cuts and concerns of 

stakeholders about the infrequent GLP inspections. For example, OECA officials 

have informally discussed the possibility of charging user fees that may be used

to fund the GLP program, as the U.S. Food and Drug Administration (FDA) and 

many other countries do, but the agency has not conducted a formal evaluation 

of user fees. Without formally assessing the need for such fees, EPA cannot 

determine whether charging and retaining the fees would be possible and 

whether such fees could help make the inspection program self-sustaining. 

EPA rarely uses GLP inspection results in making its initial pesticide registration 

decisions. An OPP official said that this is because most inspections occur after 

decisions have been made. OPP officials said they have not denied or revoked 

any pesticide registrations based on OECA GLP inspections during the past 5 

years, but OPP has taken other actions, such as requiring that a study be 

repeated because of subsequent laboratory inspection information. According to 

EPA officials, OPP and OECA have communicated on an informal basis about 

OPP’s inspection priorities before a pesticide registration has taken place. 

EPA and FDA do not regularly collaborate on laboratory inspections and may be 

duplicating each other’s work at some of these laboratories. In 1984, EPA and 

FDA entered into an agreement to collaborate on GLP inspections and met 

quarterly to discuss upcoming inspections; the agreement ended in 2004 

although meetings continued until 2007. From fiscal year 2005 to 2012, EPA and 

FDA conducted a total of 170 GLP inspections of the same 37 laboratories. In 38

of 170 inspections, the agencies inspected the same laboratory during the same 

fiscal year. EPA and FDA have independent but similar sets of GLP regulations. 

Officials from both agencies said it would be useful to know which laboratories 

the other agency was planning to inspect and to have those inspection results, 

since each agency can only inspect a certain number of laboratories each year. 

Absent collaboration and information sharing with FDA on planned and 

completed GLP inspections, EPA will have difficulty efficiently using its limited 

resources to increase the number of inspections it conducts.

View GAO-14-289. For more information, 

contact John Neumann at (202) 512-3841 or 

neumannj@gao.gov
Page i GAO-14-289 Good Laboratory Practices

Letter 1

Background 5

EPA Has Inspected Few Laboratories for GLP Compliance and 

Faced Challenges in Selecting Laboratories for Inspections 15

EPA Rarely Used GLP Inspection Results in Initial Pesticide 

Registration Decisions but Sometimes Used Them for Later 

Reexamination 23

EPA and FDA Do Not Regularly Collaborate on Laboratory 

Inspections and May Be Duplicating Each Other’s Work 27

Conclusions 31

Recommendations for Executive Action 32

Agency Comments and Our Evaluation 33

Appendix I Objectives, Scope and Methodology 35

Appendix II Web-Based Survey to Laboratories 38

Appendix III Laboratories Inspected for GLP Compliance by EPA and FDA, 

FY 2005-2012 41

Appendix IV Comments from the Environmental Protection Agency 48

Appendix V Comments from the Department of Health and Human Services 50

Appendix VI GAO Contact and Staff Acknowledgments 52

Contents
Page ii GAO-14-289 Good Laboratory Practices

Tables

Table 1: Number of Pesticide Studies Submitted, Inspections, FullTime Equivalents, and Budget for EPA’s Good Laboratory 

Practices (GLP) Compliance Monitoring Program from 

Fiscal Year 2009 to Fiscal Year 2013 16

Table 2: Actions by EPA’s Office of Pesticide Programs Based on 

Good Laboratory Practices (GLP) Inspection Results, 

Fiscal Years 2008 to 2012 25

Table 3: Average Time from EPA’s Office of Compliance and 

Assurance’s (OECA) Good Laboratory Practices (GLP) 

Inspection of Laboratory to EPA’s Office of Pesticide 

Program’s (OPP) Review of Inspection’s Impact on 

Laboratory’s Study, Fiscal Year 2008 to Fiscal Year 2012 25

Figures

Figure 1: The Role of Good Laboratory Practices in the Pesticide 

Registration Process 8

Figure 2: EPA Office of Enforcement and Compliance Assurance 

(OECA) GLP Compliance Monitoring Program’s 

Inspection Process 14

Figure 3: Laboratories Inspected for GLP Compliance by EPA and 

FDA, FY 2005-2012 42
Page iii GAO-14-289 Good Laboratory Practices

Abbreviations

CFO Chief Financial Officer

EPA Environmental Protection Agency

FDA Food and Drug Administration

FFDCA Federal Food, Drug and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

GLP Good Laboratory Practices

HHS Department of Health and Human Services

IBT Industrial Bio-Test Laboratories

ICIS Integrated Compliance Information System

LISA Laboratory Information and Study Audit

MAD Mutual Acceptance of Data

OCE Office of Civil Enforcement

OCEFT Office of Criminal Enforcement, Forensics and 

Training

OECA Office of Enforcement and Compliance Assurance

OECD Organisation for Economic Co-operation and 

Development

OIG Office of Inspector General

OMB Office of Management and Budget

OPP Office of Pesticide Programs

OPPIN Office of Pesticide Program Information 

Network

PRIA Pesticide Registration Improvement Act of 2003

TSCA Toxic Substances Control Act

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Page 1 GAO-14-289 Good Laboratory Practices

441 G St. N.W.

Washington, DC 20548

May 15, 2014

The Honorable Paul D. Tonko

Ranking Member

Subcommittee on Environment and the Economy

Committee on Energy and Commerce

House of Representatives

Dear Mr. Tonko:

Pesticides that are used to destroy or control weeds, unwanted insects, 

fungi, rodents, bacteria and other pests contribute to agricultural 

productivity by preventing crop damage and improving public health by 

controlling disease carrying pests. However, the use of pesticides may 

also have adverse effects on human health and the environment. For 

example, some pesticides in large doses may contribute to the risk of 

cancer and other serious human health problems and may also cause 

environmental damage, such as contamination of water supplies or 

unintended impacts on species not targeted by the pesticide. The Federal 

Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended,1

generally requires registration of pesticides and authorizes the 

Environmental Protection Agency (EPA) to limit the distribution and sale

of unregistered pesticides to the extent necessary to prevent 

unreasonable adverse effects on the environment.2 Under FIFRA 

implementing regulations, EPA reviews applications for pesticide products 

and registers those that it determines will meet the FIFRA statutory 

standards for registration.3

 1

Act of June 25, 1947, ch. 125, 61 Stat. 163 (codified as amended at 7 U.S.C. §§ 136-

136y).

EPA also inspects the laboratories where 

these pesticides are first tested for safety. Laboratories must conduct 

studies in support of pesticide registration applications in accordance with 

regulations called Good Laboratory Practices (GLP), which are intended 

2

7 U.S.C. § 136a(a).

3

40 C.F.R. pts. 152-180.
Page 2 GAO-14-289 Good Laboratory Practices

to ensure the quality and integrity of data.4

To monitor a laboratory’s GLP compliance with these standards, EPA 

conducts both an audit of the studies conducted by the laboratory and 

submitted to EPA and an on-site inspection of the laboratory; these two 

types of reviews together are referred to as a GLP inspection.

GLP regulations were

developed and promulgated in the United States during the late 1970s 

and early 1980s in response to fraudulent laboratory activities and poor 

laboratory practices that occurred during that time.

5 EPA’s 

Office of Pesticide Programs (OPP) reviews studies that support 

applications for registration of pesticide products submitted by study 

sponsors and makes registration decisions based on whether or not the 

pesticide products meet the FIFRA standard for registration.

6 EPA’s 

Office of Enforcement and Compliance Assurance (OECA) has a 

Compliance Monitoring Program that conducts inspections to ensure that 

laboratories comply with the agency’s GLP regulations. If OECA’s 

inspectors find a problem with the studies they audit7

The Food and Drug Administration (FDA), an agency of the Department 

of Health and Human Services (HHS), also requires that laboratories 

follow FDA’s GLP regulations, promulgated under the Federal Food, Drug 

or the laboratories 

they inspect, OECA submits this information to OPP for reexamination of 

the studies to ensure that the data they generated are valid and reliable to 

support pesticide decisionmaking. If OPP determines the data upon which 

a registration decision was based are not valid or reliable, it can ask the 

manufacturer of the pesticide to repeat a study, or it may initiate steps to 

change a registration decision.

 4

EPA implements two sets of regulations setting forth GLP standards—one under FIFRA, 

see 40 C.F.R. pt. 160, and one under the Toxic Substances Control Act (TSCA), Pub. L. 

No. 94-469, 90 Stat. 2003 (1976) (codified as amended at 15 U.S.C. §§ 2601-2697), see 

40 C.F.R. pt. 792. According to EPA officials, most of its GLP inspections are conducted 

under FIFRA. For that reason, we have focused on GLP standards under FIFRA in this 

report.

5

A “laboratory” in this report is defined as a facility where a study or part of a study is 

conducted. A laboratory can conduct its testing either indoors or outdoors at a field site.

6

EPA regulations define a sponsor as (1) a person who initiates and supports, by the 

provision of financial or other resources, a study; (2) a person who submits a study to EPA 

in support of an application for a research or marketing permit; or (3) a testing facility, if it 

both initiates and actually conducts the study. 40 C.F.R. § 160.3.

7

We are using the term “audit” to refer to the OECA inspectors’ examination of studies.
Page 3 GAO-14-289 Good Laboratory Practices

and Cosmetic Act (FFDCA)8 for conducting nonclinical laboratory studies 

of investigational drugs, medical devices, food additives, and other 

products to ensure the quality and integrity of the safety data.9

Environmental and other groups have raised concerns about OPP’s 

pesticide registration program, as we reported in August 2013,

In some 

cases, EPA and FDA receive studies from the same laboratories.

10

You asked us to review EPA’s GLP Compliance Monitoring Program. This 

report examines the extent to which (1) EPA inspects for GLP compliance 

laboratories that test pesticides and the challenges, if any, EPA faces in 

doing so; (2) EPA uses the information obtained through GLP laboratory 

inspections in its pesticide decision-making process; and (3) EPA and 

FDA collaborate on GLP inspections.

when we 

recommended that EPA take steps to improve the program. Pesticide 

manufacturers have also expressed concern about how infrequently 

OECA conducts GLP inspections, which they have stated affects firms’

ability to register and market their products in the United States and 

abroad.

To conduct this work, we reviewed relevant laws, regulations, EPA and 

FDA guidance, EPA data on pesticide studies, and GLP inspection 

results. We interviewed OECA and OPP officials, as well as FDA officials. 

We reviewed recent literature related to GLP, including information and 

documents found on the websites of a variety of industry, international, 

environmental, and academic organizations, and foreign government GLP 

inspection programs. To determine the extent to which EPA inspects for 

GLP compliance laboratories that test pesticides, we collected and 

analyzed documentation from EPA officials on its GLP inspection process 

and analyzed EPA laboratory and inspection data, the agency’s use of 

 8

Act of June 25, 1938, ch. 675, 52 Stat.1040 (codified as amended at 21 U.S.C. §§ 301-

399f).

9

21 C.F.R. pt. 58.

10EPA reviews health and environmental effects data submitted by a company and may 

register a pesticide or, alternatively, grant a “conditional registration” for a pesticide under 

certain circumstances, even though some of the required data may not have been 

submitted or reviewed. We recommended, in part, that EPA consider and implement 

options for an automated system to better track conditional registrations. See GAO, 

Pesticides: EPA Should Take Steps to Improve Its Oversight of Conditional Registrations, 

GAO-13-145 (Washington, D.C.: Aug. 8, 2013). 
Page 4 GAO-14-289 Good Laboratory Practices

the data, and the accuracy and completeness of the data. We determined 

that inspection data were sufficiently reliable to present results on the 

number of inspections conducted during fiscal year 2009 to fiscal year 

2013, based on a comparative analysis of inspection data contained in 

two of EPA’s databases and interviews with agency officials. We 

determined that data on laboratories’ identification numbers and 

addresses were not sufficiently reliable to assess the number and location 

of laboratories that had conducted studies submitted to EPA and, as a 

result, were subject to a GLP inspection. We determined the data were 

not sufficiently reliable, based on our analysis of the data, identification of 

erroneous data, and interviews with agency and laboratory 

representatives. However, EPA did provide estimates of the number and 

percentage of eligible laboratories that were inspected each year, and we 

used that information in this report. We obtained opinions on the GLP 

inspection program, including potential challenges, by interviewing 

individuals representing 25 entities, including laboratories; pesticide 

manufacturers; international organizations; environmental and health 

organizations; national and trade associations; and foreign government 

GLP programs, which we selected based on referrals from various 

stakeholders and EPA officials. In addition, we obtained survey 

responses from 20 laboratories of a nongeneralizable random sample of 

53 laboratories and other entities that had sent supporting studies to OPP 

for a pesticide registration application for fiscal year 2010 to fiscal year 

2012 to determine if they had been inspected by EPA11

 11While we received a total of 26 survey responses from our sample of laboratories, 6 of 

the 26 reported that they were not a laboratory and did not conduct GLP testing. 

Therefore, these 6 are considered out-of-scope for reporting our survey results. See 

appendix I for more detail.

(see app. II). If 

they had not had a GLP inspection, we asked what impact, if any, they 

thought not having a GLP inspection had on their business. Although the 

results of this sample are not generalizable, the laboratories were 

randomly selected, and the results can illustrate such laboratories’

experiences and challenges with GLP inspections. To assess the extent 

to which OPP uses the information obtained through GLP laboratory 

inspections in its pesticide registration decision-making process, we 

analyzed relevant documents and databases to determine the number of 

OECA’s GLP inspections that produced results that were referred to OPP 

for reexamination, the time it took to conduct these reexaminations, and 

any impact the inspections had on OPP’s pesticide registration decisions. 

To determine the extent to which EPA and FDA collaborate on 
Page 5 GAO-14-289 Good Laboratory Practices

inspections, we analyzed EPA and FDA GLP laboratory inspection data. 

We determined that the inspection data were sufficiently reliable for our 

purposes. We also analyzed the 20 survey responses to determine if the 

laboratories had conducted GLP tests or studies for submission to both 

EPA and FDA since 2008. We reviewed agency documents, such as a 

1984 interagency agreement between EPA and FDA to cooperate on 

GLP inspections, and we interviewed EPA and FDA officials and 

laboratory representatives about the potential for the two agencies to 

collaborate. Appendix I contains more detailed information on our 

objectives, scope, and methodology.

We conducted this performance audit from November 2012 to May 2014 

in accordance with generally accepted government auditing standards. 

Those standards require that we plan and perform the audit to obtain 

sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives.

The primary federal laws that govern how EPA regulates pesticides in the 

United States are FIFRA and FFDCA. Under FIFRA, EPA registers 

pesticides distributed, used, or sold, in the United States and prescribes 

labeling and other regulatory requirements to prevent unreasonable 

adverse effects on health and the environment.12 If use of a pesticide 

would result in a residue of the substance in or on food, EPA may not 

register a pesticide under FIFRA unless, among other things, it can 

determine that the residue is “safe” as defined by section 408 of the 

FFDCA.

13

 12The phrase “unreasonable adverse effects on the environment” is defined in FIFRA, in 

part, to mean (1) any unreasonable risk to man or the environment, taking into account the 

economic, social, and environmental costs and benefits of the use of any pesticide or (2) a 

human dietary risk from residues that result from a use of a pesticide in or on any food 

inconsistent with the standard for tolerance under section 408 of the Federal Food, Drug, 

and Cosmetic Act, 21 U.S.C. § 346a. This standard requires EPA to consider both the 

benefits and risks of using a pesticide. 7 U.S.C. § 136(bb).

EPA may establish a tolerance level—the maximum

permissible pesticide residue in or on food or animal feed that is sold—

that meets the FFDCA safety standard set forth in section 408 or may 

13Under section 408 of the FFDCA, “safe” means that EPA has determined, among other 

things, that there is a reasonable certainty that no harm will result from aggregate 

exposure to the pesticide residue. 21 U.S.C. § 346a(b)(2)(A)(ii). 

Background
Page 6 GAO-14-289 Good Laboratory Practices

choose to grant an exemption for a tolerance. To obtain a pesticide 

registration, or petition to establish a tolerance level, a registrant 

(company or person) submits an application for EPA’s review containing 

health and environmental effects data and other information on a 

pesticide.14

Under FIFRA, when a registrant submits an application for pesticide 

products to OPP, the accompanying data to support the registration are 

required to be prepared in accordance with the agency’s GLP regulations

to ensure the quality and integrity of the data in the study. Each study 

submitted is reviewed by OPP to see if GLP criteria have been met. OPP 

staff prepare science reports and/or data evaluation records to address 

the quality of each study. If studies submitted in support of this process 

contain questionable data, this can result in adverse action by OPP. For 

example, according to OPP officials, if OPP finds that a registrant 

provided false or inaccurate information about the certified limits of the 

active ingredients of a pesticide, or if there is a discrepancy in the number 

of formulas used to check concentrations, a study would be rejected, and 

OPP might deny such an application or request that it be withdrawn.

In addition to testing conducted in a laboratory, these data 

can include studies based on the analysis of data collected from field 

applications of the pesticide and other information on the pesticide. The 

application is submitted with a pesticide registration fee, with the fee 

amount depending on certain factors, such as the type of registration 

action that is being requested. According to an OPP official, registrants 

are required to provide data relating to the pesticide’s hazard and 

exposure levels to accompany a proposed registration. All studies 

submitted in support of a product registration are subjected to an initial 

screening and regulatory and scientific review by OPP staff to determine 

potential human and environmental risks. OPP reviews the applications 

and registers those products determined to meet FIFRA’s standards for 

registration and other regulatory requirements so that they can be 

marketed domestically.

OECA’s GLP Program is tasked with monitoring compliance with the GLP 

regulations through on-site inspections of laboratories, as well as audits 

of the laboratories’ studies. According to EPA officials, the purpose of the 

 14According to OPP officials, applicants for pesticide registrations are usually pesticide 

product manufacturers. When EPA registers an applicant’s pesticide product, the 

applicant is then called a registrant. For the purposes of this report, we refer to both 

applicants and registrants as registrants. 
Page 7 GAO-14-289 Good Laboratory Practices

study audit is to ensure that the study was conducted in accordance with 

the agency’s GLP regulations and that the study is supported by data 

generated by the laboratory. A study’s sponsor or applicant must include 

one of the following statements in the submission: (1) that the study was 

conducted in accordance with GLP, (2) a detailed description of all the 

differences between the practices used in the study and those required by 

GLP, or (3) that they do not know if their study was conducted in 

accordance with GLP.15

 1540 C.F.R. § 160.12. 

Laboratories eligible for inspection are those that 

have conducted studies submitted to the agency. In some instances, a 

single laboratory may have conducted more than one submitted study. 

During an inspection, OECA’s GLP Program inspectors will verify the 

accuracy of a study’s GLP compliance statement. GLP inspections can 

take place while OPP is still reviewing a pesticide registration application 

or a petition for a tolerance-setting, or it can take place after a pesticide 

has been registered, or the tolerance has been established. Figure 1 

summarizes the pesticide registration and tolerance-setting process, as 

well as its relationship to OECA’s inspection of GLP laboratories.
Page 8 GAO-14-289 Good Laboratory Practices

Figure 1: The Role of Good Laboratory Practices in the Pesticide Registration Process

EPA and FDA have each developed their own GLP standards to address 

problems found with laboratory studies submitted for the agencies’

review. Investigations by these agencies in the mid-1970s revealed that 

some studies had not been conducted in accordance with commonly 

accepted laboratory practices. For example, according to an industry 

representative, one of the first laboratories to attract regulatory and media 

attention was Industrial Bio-Test Laboratories (IBT), a contract 

toxicological research laboratory that conducted much of the U.S. 

toxicological testing at the time. As a result of EPA’s and FDA’s 

investigations of IBT, several hundred studies were invalidated because 
Page 9 GAO-14-289 Good Laboratory Practices

of deliberate fraud, and hundreds of chemicals had to be retested. 

Specific findings included poor recordkeeping, testing conducted by 

untrained and unqualified personnel, and data fabrication. For example, 

data were submitted on rats that had previously been reported as 

deceased. As a result, in 1978, FDA formulated and published GLP 

regulations under FFDCA.16 In 1983, EPA published its GLP standards 

for pesticide toxicology studies, and in 1989, EPA extended the 

standards’ coverage to include nearly all research data supporting 

pesticide registrations under FIFRA. The Organisation for Economic Cooperation and Development (OECD), which includes more than 30 

member countries including the United States, published OECD 

Principles of Good Laboratory Practices and OECD Guidelines for the 

Testing of Chemicals in 1981.17

GLP standards cover the proper handling of laboratory test substances, 

equipment maintenance and calibration, testing operations, study plans, 

quality assurance, recordkeeping and reporting requirements, and facility 

management, among other things. For example, when EPA conducts a 

GLP inspection, it determines, among other things, whether the laboratory 

is of suitable size and construction to facilitate the proper conduct of the 

studies. Specifically, an EPA inspection would determine, among other 

things, whether the laboratory has a sufficient number of rooms or other 

areas for proper separation of species and testing, as well as for the 

collection and disposal of contaminants and waste.

In 1981, OECD established the Mutual Acceptance of Data program 

designed to obtain international recognition of testing data in support of 

pesticide registrations. As of August 2012, there were 31 member 

countries, including the United States, and 5 nonmember countries, each 

participating on a rotating basis in evaluating each other’s testing 

programs compared with OECD test guidelines. EPA has signed 

memorandums of understanding with seven countries under the Mutual 

 1643 Fed. Reg. 59,986 (Dec. 22, 1978) (codified as amended at 21 C.F.R. pt. 58).

17OECD is an organization of 34 industrialized countries, operating by consensus, that 

fosters dialogue among members to discuss, develop, and refine economic and social 

policies and provides an arena for establishing multilateral agreements.
Page 10 GAO-14-289 Good Laboratory Practices

Acceptance of Data Program and has a bilateral agreement with China.18

EPA’s GLP inspection process includes three stages: (1) the 

preinspection targeting stage, (2) the inspection stage or on-site 

inspection of the laboratory, and (3) the postinspection stage.

According to EPA documents, U.S. companies seeking to sell pesticides 

in foreign countries and multinational companies seeking registration of 

pesticides to sell in the United States must meet two Mutual Acceptance 

of Data program criteria: (1) the country where a study was conducted 

has a valid and active GLP Compliance Monitoring Program and (2) the 

testing facility (or laboratory) was inspected by the country’s GLP 

compliance monitoring authority. Some other countries fund their GLP 

inspections through fee-based systems, under which the registrant or 

laboratory pays a portion or all of the inspection costs. For example, 

according to a European Commission official, there are currently 17 

European Union member countries that charge some type of fee for 

conducting GLP inspections. According to FDA officials, FDA charges 

user fees for medical and animal product application reviews; these fees,

together with appropriated funds, provide resources that FDA uses for 

conducting GLP inspections related to such products. According to EPA 

officials, although the agency charges fees for review of pesticide 

applications by OPP, it does not charge a fee for OECA’s GLP laboratory 

inspections.

The preinspection targeting stage includes a series of activities performed 

by inspectors before the actual on-site inspection is conducted. OECA’s 

GLP Compliance Monitoring Program usually initiates its own inspections 

by using a targeting module—referred to as the “Neutral Scheme 

Targeting Module”—that automatically searches the GLP Program’s 

Laboratory Information and Study Audit (LISA) database to target 

potential studies and pesticide test laboratories. The GLP Compliance 

Monitoring Program selects laboratories for inspection from among the 

population of laboratories that have conducted studies submitted to 

 18EPA has signed a memorandum of understanding with Canada, Germany, Israel, 

Japan, the Netherlands, Switzerland, and the United Kingdom. In addition, EPA has 

signed a Letter of Intent with China to mutually accept each other’s GLP Program upon 

completion of certain criteria, and the U.S. Ambassador signed a bilateral agreement with 

Taiwan.

Preinspection Targeting Stage
Page 11 GAO-14-289 Good Laboratory Practices

OPP.19 Using the Neutral Scheme Targeting Module, the inspector 

identifies laboratories and applies numerical weights to them based on a 

set of criteria (e.g., the length of time since the last inspection, the 

severity of the last and prior inspection findings, and the number of 

submitted studies conducted by the laboratory) to establish a list of 

potential laboratories to inspect. Most laboratories are selected for 

inspection through the Neutral Scheme Targeting Module.20

Inspections can also be initiated at OPP’s request or that of another EPA 

office. For example, as OPP reviews studies, it may have questions or 

problems with the supporting data. In those cases, OPP can request that 

OECA’s GLP Program conduct an audit of particular studies and inspect 

the laboratories used for these studies. In addition, according to EPA 

officials, foreign governments can request an EPA inspection if a U.S. 

registrant is applying to use its pesticide in a foreign country and that 

country requires a GLP inspection of the U.S. laboratories whose studies 

are to be used in support of the registration. Finally, according to EPA 

officials, OECA can conduct a “for cause” GLP inspection based on a tip 

When 

laboratories are identified for inspection through use of the Neutral 

Scheme Targeting Module, the GLP Program Manager assesses these 

laboratories to determine their eligibility for inspection along with the 

studies selected for audit. The assessment includes performing a 

preliminary review of studies to determine, among other things, whether 

the laboratory is still in business and whether any studies conducted by 

the laboratory have been rejected by OPP in a review of a pesticide 

application. The GLP Program Manager will then prioritize and select the 

laboratories for inspection. Criteria for selection can include whether the 

eligible laboratories are in the same geographic area. The inspector 

determines when the laboratory will be inspected and, 10 days prior to the 

inspection, notifies the laboratory of the impending inspection.

 19When pesticide registration application or tolerance level petitions are submitted to OPP, 

contractors enter laboratory data, such as laboratory name and address, as well as 

information on the studies submitted with the application, into the Office of Pesticide 

Program Information Network (OPPIN) database. At any given time, LISA only contains 

data submitted to OPP for the previous 5 years. The data are transferred to LISA from 

OPPIN. In contrast to EPA’s process, officials from other countries told us that their GLP 

compliance monitoring programs select laboratories for inspection before these 

laboratories begin GLP testing.

20Some laboratories are identified for inspection through other means, such as complaints 

submitted.
Page 12 GAO-14-289 Good Laboratory Practices

or complaint received through anonymous phone calls, e-mails or letters 

about potential GLP violations at a laboratory.

The inspection stage begins with the OECA inspectors, prior to visiting a 

laboratory, conducting study audits and evaluating the laboratory studies 

submitted to OPP to determine whether they adhere to GLP standards. 

GLP Compliance Monitoring Program inspectors previously performed 

this data audit during the inspection of the laboratory. In April 2012, EPA 

changed its process to have inspectors audit studies before inspecting 

the laboratory to save time spent at the laboratory and therefore reduce 

travel expenses. However, OECA officials told us that its inspectors follow 

the old process if appropriate to the situation. The inspectors are also to 

verify that data generated by the laboratory support the conclusions made 

in the study.

Next, an inspector travels to the laboratory to perform the on-site 

inspection of the laboratory. As part of this inspection, the inspector 

performs a walk-through of the laboratory to gain an understanding of its 

capabilities. The inspector will ask to see and review inspection

documentation associated with the laboratory, including qualifications and 

responsibilities of laboratory personnel, the receipt and storage of test 

substances, the laboratory’s standard operating procedures, and animal 

rooms. The inspector then conducts a compliance inspection to gauge the 

laboratory’s current practices and procedures by selecting one or two 

ongoing or recently completed studies from the laboratory’s master 

schedule to see whether they adhered to GLP standards. The inspector 

also observes a procedure in an ongoing study to determine adherence to 

standard operating procedures, the study plan, and GLP, as well as 

whether the person performing the procedure has the appropriate 

education and experience.

The postinspection stage involves activities such as preparing an 

inspection report that contains a description of the general nature of the 

inspection and the laboratory being inspected. Report appendixes cover 

the findings from the study audits and the on-site inspection. Inspection 

reports are next reviewed by another GLP inspector to ensure the reports 

are complete and consistent. According to an EPA official, the GLP 

Program Manager then reviews the inspection report and assigns one of 

the following categories to the laboratory as specified in the Enforcement 

Response Policy for FIFRA GLP Regulations: (1) no GLP deficiencies 

noted, (2) minor GLP deviations, or (3) major/significant GLP violations. 

For laboratories given ratings in the first two categories, the inspector 

closes out the inspection and enters all the inspection information and the 

Inspection Stage

Postinspection Stage
Page 13 GAO-14-289 Good Laboratory Practices

review category into the LISA database. The inspector also enters some 

of this information, such as laboratory information, inspection dates, 

number of study audits, and potential deficiencies, into OECA’s Integrated 

Compliance Information System (ICIS), which is used for OECA-wide 

compliance reporting results.

The GLP Program Manager sends a letter to the laboratory and the 

registrant notifying them of the results of the inspection and, in the case of 

any deficiencies, requesting assurances that appropriate action will be 

taken to remedy the deficiencies. In the case of a significant violation of 

the GLP standards that, in the opinion of the inspector, may have affected 

the validity and integrity of studies performed at the laboratory, the GLP 

Program Manager will refer this information to OPP for consideration in 

their decision-making process and, if appropriate, to OECA’s Office of 

Civil Enforcement (OCE), which develops and prosecutes administrative 

civil and judicial cases and provides legal support for cases and 

investigations initiated in EPA regions. If the violation is criminal in nature, 

it will be referred to OECA’s Office of Criminal Enforcement, Forensics

and Training (OCEFT). The inspection will not be closed until OPP or 

OECA has made a final determination. Figure 2 summarizes the GLP 

inspection process.
Page 14 GAO-14-289 Good Laboratory Practices

Figure 2: EPA Office of Enforcement and Compliance Assurance (OECA) GLP 

Compliance Monitoring Program’s Inspection Process

a

The GLP Program Manager will refer significant violations of the GLP standards to OPP and, if 

appropriate, to OECA’s OCE. If a violation is criminal in nature, it will be referred to OECA’s OCEFT.
Page 15 GAO-14-289 Good Laboratory Practices

EPA’s OECA has inspected few laboratories on an annual basis that test 

pesticides for GLP compliance for fiscal year 2009 through fiscal year 

2013 and faced challenges in doing so. Because of resource limitations in 

the GLP Compliance Monitoring Program, OECA prioritizes laboratories 

for GLP inspections based on a set of criteria. However, our analysis 

showed that some laboratory information in the databases used to 

prioritize laboratories for inspection was either inaccurate or incomplete, 

and these data challenges may negatively affect prioritization. OECA 

officials said that budget cuts, among other things, have reduced the 

number of inspectors and the number of GLP inspections that can be 

performed. Given the concerns of some stakeholders about the infrequent 

GLP inspections, OECA is considering other approaches, such as 

charging fees or using third parties to review studies, in order to increase 

the number of inspections.

OECA inspected from 51 to 80 laboratories each year for GLP 

compliance in fiscal year 2009 to fiscal year 2013, but most laboratories 

were not regularly inspected for GLP compliance. During this period, 

OECA inspected about 4 to 6 percent of 1,400 eligible laboratories each 

year, according to EPA data and officials.21 In contrast, FDA’s GLP 

compliance program guidance manual states that the program’s objective 

is to inspect all eligible nonclinical laboratories conducting safety studies 

that are intended to support applications for research or marketing of 

regulated products approximately every 2 years.22

Some laboratory representatives we surveyed stated that their 

laboratories were not inspected for GLP compliance by EPA from 2008 to 

2013. EPA officials told us they inspect as many laboratories as they can,

given financial constraints. OECA officials explained that a limited number 

of inspectors and tight budgets have hindered their ability to perform more 

inspections. In fiscal year 2013, according to EPA officials, OECA had 

four GLP inspectors to inspect 1,400 eligible laboratories in the United 

Similarly, most 

member countries under OECD’s Mutual Acceptance of Data (MAD) 

agreement conduct inspections of their laboratories for GLP compliance 

every 2 years, according to an OECD official we interviewed.

 21According to EPA officials, approximately 1,400 laboratories conducted studies that 

were submitted to EPA over a 5-year time frame and are thus eligible for inspection.

22FDA Compliance Program Guidance Manual 7348.808.

EPA Has Inspected 

Few Laboratories for 

GLP Compliance and 

Faced Challenges in 

Selecting 

Laboratories for 

Inspections

OECA Inspects Few 

Laboratories Annually, but 

Most Laboratories Are Not 

Regularly Inspected for 

GLP Compliance
Page 16 GAO-14-289 Good Laboratory Practices

States. OECA officials acknowledged that their four inspectors cannot 

inspect all 1,400 eligible laboratories for GLP compliance every 2 years. 

From fiscal year 2009 to fiscal year 2013, EPA reduced its GLP 

Compliance Monitoring Program budget and the number of full-time 

equivalent staff by approximately 50 percent from eight to four inspectors. 

EPA officials said that the reduction in the number of full-time equivalent 

staff was due to retirements, an inability to hire new inspectors because 

of budgetary constraints, and most importantly, according to these 

officials, the inability to find inspector candidates with the requisite skills. 

During this same time period, the number of studies conducted by 

laboratories that were submitted to OPP has remained relatively constant, 

except for an increase in the number of studies submitted in fiscal year 

2010. Estimates of the numbers of studies submitted, inspections 

conducted, inspection staff and GLP budget data are shown in table 1.

Table 1: Number of Pesticide Studies Submitted, Inspections, Full-Time 

Equivalents, and Budget for EPA’s Good Laboratory Practices (GLP) Compliance 

Monitoring Program from Fiscal Year 2009 to Fiscal Year 2013

FY 2009 FY 2010 FY 2011 FY 2012 FY 2013

Number of pesticide 

studies submitted to EPA 7,791 a 10,093 8,715 8,326 7,123

Number of GLP 

inspections 64 b 71 c 51 c 80 c 79 c

Number of GLP 

compliance monitoring 

program full-time 

equivalents

c

8 8 5 4 4

GLP program budget $1,415,000 $1,021,400 $959,500 $734,500 $702,000

Source: GAO analysis of EPA data.

a

Multiple studies can, and do, come from the same laboratory.

b

These numbers include inspections performed under the Federal Insecticide, Fungicide, and 

Rodenticide Act and exclude inspections conducted under the Toxic Substances Control Act.

c

Inspection data were taken from EPA’s Integrated Compliance Information System database 

because of technical problems EPA has been experiencing with the Laboratory Information and Study 

Audit database since July 2011.

To increase efficiency and to respond to a reduced budget and workforce, 

as well as to address concerns from industry and the OECD, OECA 

implemented changes to its GLP inspection procedures in fiscal year 

2012 to try to increase the number of GLP inspections from the low of 51 

conducted in fiscal year 2011. Under its revised inspection procedures, 

agency officials consider laboratories’ geographic proximity to each other, 

as well as other criteria, when selecting laboratories to inspect. For 

example, in February 2013, the agency inspected five laboratories 
Page 17 GAO-14-289 Good Laboratory Practices

located in Oregon and, in March 2013, the agency inspected two 

laboratories in Texas. OECA officials explained that grouping laboratory 

visits geographically saves travel money and staff time. In addition, they 

stated that a change in OECA’s inspection procedures to allow inspectors 

to audit studies in EPA offices rather than on-site reduced the amount of 

time that inspectors spent at a laboratory.

Nevertheless, some stakeholders and international officials we 

interviewed expressed concern about the infrequent GLP inspections by 

EPA. Pesticide manufacturers and industry associations told us that if 

laboratories cannot prove GLP compliance to potential clients or to 

countries where their products may be used, their business can be 

negatively affected. According to a senior staff person at one U.S. 

laboratory, in 2011, the Netherlands rejected a study from a U.S.-based 

laboratory because the contractor laboratory that conducted the study 

had not been inspected by EPA. This same study had been previously 

submitted to EPA. Following the Netherlands’ rejection of this study, the 

laboratory had to repeat the study and subsequently contracted with a 

European-based laboratory to do so. In addition, two stakeholders we 

interviewed said that such rejections by other countries could likely 

increase if U.S laboratories could not show that they had a recent GLP 

inspection. One laboratory representative said his laboratory may stop 

doing GLP testing since many registrants require proof of GLP 

inspections, and his laboratory had not been inspected by EPA. In 

addition, this laboratory representative said that if U.S. laboratories 

cannot show that they have had a GLP inspection, registrants may not 

hire them to conduct studies because of the possibility that those studies 

may be rejected. In our survey of laboratories, 5 of 14 respondents 

reported that EPA could improve its implementation of its GLP 

Compliance Monitoring Program by increasing the number and frequency 

of inspections to prevent these business consequences.23

 23Not all respondents to our survey answered every question. We obtained survey 

responses from 20 laboratories from a nongeneralizable, random sample of 53 

laboratories, and other entities that had sent supporting studies to OPP for a pesticide 

registration application for fiscal year 2010 to 2012 to ask them questions about EPA’s 

GLP inspections. Please see appendix I for details.

Twelve of 15 

respondents from laboratories with study data submitted to OPP since 

fiscal year 2008 reported that EPA’s GLP inspections had a positive effect 

on their business. Nine of the 12 respondents who reported positive 

effects of a GLP inspection indicated that the inspections enabled them to 
Page 18 GAO-14-289 Good Laboratory Practices

prove GLP compliance to their customers, such as U.S. and international 

pesticide manufacturing companies, as well as to other countries’

governments.

OECA prioritizes laboratories for GLP inspections, but challenges with 

some of the data used to determine those priorities may negatively affect 

its targeting process. GLP Compliance Monitoring Program inspectors 

use the OPPIN and LISA databases to develop a list of the highest 

priority laboratories to inspect for GLP compliance in a given year. Once a 

list is generated using the Neutral Scheme Targeting Module located in 

the LISA database, OECA officials said they try to select laboratories that 

are geographically near to one another to inspect. The information used 

to develop this priority list is based on data transferred from OPPIN to 

LISA. However, our analysis showed that the laboratories’ information in 

these databases was sometimes incomplete or inaccurate.24

We found that the OPPIN system currently has three categories to 

classify an entity’s role in a study: sponsor, performing laboratory, or both. 

These categories do not allow EPA staff to differentiate between GLP 

laboratories and other entities involved in a study. As a result, we found 

some entities were identified in the OPPIN database as “performing 

laboratories,” which EPA defines as facilities where a study or part of a 

study is conducted, when in fact they were not.25 For example, of the 

respondents to our survey of performing laboratories found in the OPPIN 

database, six reported that they were not a laboratory and did not conduct 

GLP testing.26

 24We have previously reported issues with inaccurate data in OPPIN. In August 2013, we 

reported that, according to OPP officials, following an internal review of its conditional 

pesticide registration program that it completed in March 2011, OPP concluded that the 

OPPIN data on the number of conditional pesticide registrations were inaccurate. See 

Of these six, three said they were consultants, two said 

GAO-13-145.

25In the Pesticide Registration (PR) Notice 2011-3 Standard Format for Data Submitted 

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain 

Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) published on November 

30, 2011, EPA instructs study submitters to clearly identify on each study’s title page the 

name of the performing laboratory. The guidance does not specify that a laboratory’s 

identification number be included on the title page but does specify inclusion of a 

laboratory project identifier.

26We received a total of 26 survey responses from our sample of laboratories, but 6 of the 

26 reported that they were not a laboratory and did not conduct GLP testing. Therefore, 

these 6 are considered out-of-scope for reporting our survey results.

OECA Prioritizes 

Laboratories for GLP 

Inspections, but Data 

Challenges May 

Negatively Affect Its 

Targeting Process
Page 19 GAO-14-289 Good Laboratory Practices

they contract with an outside source for laboratory testing, and one was a 

pesticide manufacturer. We were not able to determine how or why these 

entities were identified as performing laboratories in OPPIN. EPA officials 

told us that if the entity that submits the study puts inaccurate information 

on a study’s title page concerning who performed the study and where 

the study was performed, the information entered by EPA’s contractors 

into OPPIN will also be inaccurate. EPA’s documentation describing the 

Neutral Scheme Targeting of laboratories states that the entity’s role in a 

pesticide study determines whether it is a candidate for inspection. If 

entities are inaccurately identified in OPPIN as performing laboratories, 

the Neutral Scheme Targeting Module will not consider the correct 

universe of laboratories to inspect and, as a result, inspectors need to do 

additional manual research to verify that the laboratory selected for an 

inspection is indeed an entity eligible for a GLP inspection.

We also found that address information for some laboratories was 

missing or inaccurate in OPPIN. For example, we found missing address 

information for 23 percent of laboratories listed in OPPIN.27 In 2008, EPA 

updated its 1991 guidance to the contractors responsible for entering data 

into OPPIN.28

In addition, we found that some laboratory identification numbers were 

not reliable. In its November 1991 guidance, OPP states that laboratories 

should be assigned a unique laboratory identification number.

The updated guidance states that the agency wants to 

capture the physical address for each laboratory because OECA uses 

this information to select laboratories for inspection. The guidance 

acknowledges that determining the performing laboratory in published 

studies is challenging, but the goal is to identify where the actual location 

of the research was done. Without accurate address information, there 

could be problems determining where the testing was actually conducted.

29

 27Missing address information could include missing data for any of the following: street 

address, city, state, or zip code.

For 

example, we found that one laboratory that was given a ranking in fiscal 

year 2013 as second highest priority for a GLP inspection had an 

identification number that was the same as four other laboratories in four 

28EPA, Technical Guidance for Citation Building: Extra Hints for Coding Laboratories and 

Sponsors. Apr. 1, 2008.

29EPA, Revised Technical Direction for PDMS Laboratory Indexing. Nov. 1991.
Page 20 GAO-14-289 Good Laboratory Practices

different states, making it unclear which of those five laboratories was 

actually the one selected for inspection.

The agency maintains two different databases to track GLP inspections, 

ICIS and LISA. The LISA database is used by the GLP Compliance 

Monitoring Program, while the ICIS database is used EPA-wide, 

according to officials. Because of technical problems EPA has been 

experiencing with the LISA database, inspection data have been entered 

only into ICIS since July 2011, according to officials. We reviewed 

inspection data contained in both databases for fiscal year 2008 to fiscal 

year 2013 in an effort to determine the total number of GLP inspections 

OECA conducted, but we were not able to match the inspection 

information contained in the two databases. While LISA uses laboratory 

identification numbers, ICIS does not. As a result, OECA may not be able 

to track if, or when, a specific laboratory had been inspected because the 

systems do not both use identification numbers. In addition, the laboratory 

names are not always the same in the two databases. We were also 

unable to match up the inspections in the two databases. Without 

accurate data on which laboratories have been inspected, OECA’s 

Neutral Scheme Targeting Module scoring of laboratories most in need of 

inspection may be inaccurate and, therefore, manual research is required 

to ensure that OECA is targeting the laboratories most in need of 

inspection.

Based on the incomplete or inaccurate data in ICIS, LISA, and OPPIN, it 

is not always possible for GLP Compliance Monitoring inspectors to 

identify where the testing was conducted without making telephone calls 

to individual laboratories. The data issues also impede the agency’s 

ability to efficiently track which laboratories need inspecting. The officials 

said GLP inspectors must spend time manually verifying laboratory data 

before deciding which laboratories to inspect. In the absence of reliable 

data, EPA may not have the data it needs to prioritize laboratories to 

inspect efficiently or effectively.

OECA is considering other approaches to address laboratory 

representatives’ and others’ concerns about infrequent GLP inspections, 

such as using third parties or charging fees to increase the number of 

inspections. In August 2012, OECA developed a Budget Adjustment Plan, 

which provided general information on potential future approaches to the 

GLP Compliance Monitoring Program, including ways the program could 

be run more efficiently given its recent budget cuts and inability to hire 

GLP inspectors. In its Budget Adjustment Plan, EPA states that OECA 

will evaluate other implementation approaches, such as the use of a third 

OECA Is Considering 

Other Implementation 

Approaches to Increase 

Inspections
Page 21 GAO-14-289 Good Laboratory Practices

party to conduct GLP inspections. EPA officials told us that they have 

also conducted internal and informal discussions regarding the possibility 

of using user fees for the GLP program, but the agency has not 

conducted a formal evaluation of user fees. Without formally assessing 

the need for such fees, EPA cannot determine whether charging and 

retaining the fees would be possible and whether such fees could help 

make the inspection program self-sustaining. 

In 2012, we concluded that federal user fees and charges are generally 

related to some voluntary transaction or request for government goods or 

services beyond what is normally available to the public, such as fees for 

patent applications and customs inspections.30 In 2012, the federal 

government collected nearly $300 billion in user fees from the public.31 In 

2008, we found that well-designed user fees can reduce the burden on 

taxpayers to finance those portions of activities that provide benefits to 

identifiable users.32

According to Office of Management and Budget (OMB) Circular A-25, 

every 2 years, agencies should review programs that are not currently 

funded by user fees (such as the GLP program) to determine whether 

fees should in fact be assessed for government services.

As we mentioned earlier, FDA charges user fees for 

medical and animal product application reviews, and these fees, together 

with appropriated funds, provide resources that FDA uses for conducting 

GLP inspections related to such products. In addition, some other 

countries, such as some that are members of the OECD, fund their GLP 

inspections through fee-based systems, whereby the registrant or 

laboratory pays a portion or all of the inspection costs.

33

 30GAO, 2012 Annual Report: Opportunities to Reduce Duplication, Overlap and 

Fragmentation, Achieve Savings, and Enhance Revenue, 

Once user 

fees are implemented, revenue from the fees will be credited to the 

GAO-12-342SP (Washington, 

D.C.: February 2012).

31GAO, Federal User Fees: Fee Design Options and Implications for Managing Revenue 

Instability, GAO-13-820 (Washington, D.C.: Sept. 30, 2013).

32In May 2008, we issued a User Fee Design Guide, which examined how the four key 

design and implementation characteristics—how fees are set, collected, used, and 

reviewed—may affect the economic efficiency, equity, revenue adequacy, and 

administrative burden of the fees. GAO, Federal User Fees: A Design Guide, 

GAO-08-386SP (Washington, D.C.: May 2008).

33Office of Mgmt. & Budget, Circular No. A-25 Revised, Memorandum for Heads of 

Executive Departments and Establishments (July 8, 1993).
Page 22 GAO-14-289 Good Laboratory Practices

general fund of the U.S. Treasury as miscellaneous receipts unless 

otherwise specified by law.34 Circular A-25 also states that it may be 

appropriate for an agency to request authority to retain the fee revenue if 

the user fees offset the expenses of a service that is intended to be selfsustaining. The OMB guidance states that agencies are to discuss the 

results of the biennial fee reviews and any resulting proposals in their 

Chief Financial Officers (CFO) Annual Report required by the Chief 

Financial Officers Act of 1990.35 In its most recent CFO Annual Report 

(EPA Agency Financial Report) EPA discussed its biennial review of its 

existing user fee programs. However, it did not discuss reviewing the GLP 

program—or any of its other programs that are not currently funded by 

fees—to determine whether fees should be assessed.36 Moreover, in 

March 2014, the EPA Office of Inspector General (OIG) reported that 

EPA did not conduct thorough biennial user fee reviews for fiscal year 

2008 to fiscal year 2009 and for fiscal years 2010 to 2011, and it did not 

review all agency programs to determine whether they should assess 

fees for government services they provided.

37 Among the OIG’s 

recommendations were that the EPA CFO discuss biennial user fee 

results in the EPA Agency Financial Report, coordinate with programs 

that claimed an exception to charging fees and costs and help determine 

whether fees should be assessed. Without assessing the need for user 

fees, EPA cannot determine whether fees could help make the laboratory 

inspection program self-sustaining.38

When asked about user fees, representatives of 8 of 12 laboratories and 

pesticide manufacturers told us they would support EPA user fees for 

 34The rule governing the accounting and disposition of receipts, including user fees, states 

that they must be deposited in the general fund of the Treasury as miscellaneous receipts 

unless the agency has statutory authority to do otherwise. 31 U.S.C. § 3302.

35Pub. L. No. 101-576, 104 Stat. 2838 (1990).

36EPA, Fiscal Year 2013 Agency Financial Report.

37EPA Office of Inspector General, EPA Did Not Conduct Thorough Biennial User Fee 

Reviews, 14-P-0129 (Washington, D.C.: Mar. 4, 2014).

38EPA acknowledges that improvements were needed to ensure that all agency programs 

were reviewed, in accordance with OMB Circular A-25, “User Charges, Revised,” and the 

Chief Financial Officers Act of 1990. According to EPA officials, the agency took actions in 

Fiscal Year 2013 to improve its user fee review efforts by issuing a biennial user fee 

review guide, conducting training for its user fee programs, and established fee review 

procedures.
Page 23 GAO-14-289 Good Laboratory Practices

GLP inspections, and they cited more frequent GLP inspections as a 

possible benefit of such user fees. Representatives from the remaining 4 

laboratories did not support user fees, and some of these expressed 

concern that a user fee system might be burdensome to smaller 

laboratories. However, as we previously reported, the amount of a user 

fee reflects the cost of providing the service, which may differ among 

users.39

EPA rarely used GLP inspection results in making its initial pesticide 

registration decisions. An OPP official told us that this is because most 

inspections occur after those decisions have been made. According to an 

OPP official, pesticide registration decisions are required by statute to be 

made within 3 to 24 months of receipt of the pesticide application. For 

example, new pesticide products that are identical in their uses and 

formulation to one or more products already registered usually require a 

registration decision within 3 months.40

OPP and OECA officials told us that they have historically communicated 

on an informal basis about OPP’s inspection priorities before a pesticide 

registration has taken place. These priorities are usually based on OPP’s 

review of studies and the concerns that may arise from these reviews or 

about the sponsor or study performer. This informal communication 

generally involves OPP contacting OECA by telephone or e-mail to 

request that certain laboratories be inspected. An OPP official told us that 

the two offices have recently tried to make better use of the GLP 

inspection program in OPP’s decision making. For example, according to 

EPA officials, in September 2012, a senior OPP official hand-delivered a 

document to her OECA counterpart requesting that (1) several 

laboratories be considered as priorities for GLP inspections in fiscal year 

2013; (2) OECA focus its audit of studies on those submitted within the 

However, the official stated that 

the GLP Monitoring Program staff cannot set up and conduct inspections 

of many of the laboratories involved within those time frames.

 39GAO-08-386SP.

40The Pesticide Registration Improvement Act of 2003 (PRIA) provides a schedule of 

covered applications and registration service fees, including the category or type of 

application, the amount of the pesticide registration service fee, and the corresponding 

decision review timeframe in which the agency is to make a decision. There are 189 fee 

categories or types of applications, each with a fee and decision review time frame. Pub. 

L. No. 108-199, div. G, tit. V, § 501(f)(2), 118 Stat. 419, 422 (2004) (codified as amended 

at 7 U.S.C. § 136w-8).

EPA Rarely Used 

GLP Inspection 

Results in Initial 

Pesticide Registration 

Decisions but 

Sometimes Used 

Them for Later 

Reexamination
Page 24 GAO-14-289 Good Laboratory Practices

last 6 to 12 months when performing inspections under the Neutral 

Scheme Targeting Module in fiscal year 2013; and (3) OECA audit 

specific categories of studies that OPP officials considered critical to their 

pesticide approval decisions. An OECA official told us that as of March 

2014, OECA inspectors had completed all of the eight OPP-requested 

inspections. An OPP official told us that OPP would like to continue to 

provide input to OECA prior to the beginning of each fiscal year to 

increase the opportunity for OPP to react to findings before a product is 

registered. The two offices appear to be communicating and prioritizing 

laboratories for GLP inspections informally, but according to an EPA 

official, there are no documented procedures that define the 

responsibilities of each office in coordinating and prioritizing GLP 

inspections. EPA has stated that formal procedures are not needed and 

that the current method of communication and coordination is 

satisfactory. However, by relying on informal coordination mechanisms, 

OECA and OPP are depending on relationships with individual officials to 

ensure effective coordination, and these informal relationships could end 

once personnel turnover occurs. Without documented procedures for 

effective coordination between the two offices, there is no assurance that 

the two offices will consistently coordinate on GLP inspections in the 

future. Under federal standards for internal control, agencies are to clearly 

document internal controls, and the documentation is to appear in 

management directives, administrative policies, or operating manuals.41

When OECA’s GLP inspectors find deficiencies at a laboratory, they 

share the inspection reports with major or significant violations with OPP. 

According to OPP officials, once OPP receives the OECA inspection 

report, it sends it to the OPP registration division responsible for the 

registration (or pending registration) of products being supported by the 

studies audited. The OPP registration division then reviews the report and 

conducts a scientific reexamination of the studies that the laboratory in 

question conducted and that were submitted in support of the pesticide 

registration. Once OPP finishes its reexamination, if it finds that 

deficiencies affect a study’s findings, OPP is to reject the study and may 

request that the registrant repeat the study, submit other materials that 

support that aspect of the registration, or perform other corrective action 

deemed satisfactory to OPP. After the reexamination is complete, OPP 

 41GAO, Standards for Internal Control in the Federal Government, GAO/AIMD-00-21.3.1

(Washington, D.C.: November 1999).
Page 25 GAO-14-289 Good Laboratory Practices

informs both OECA’s GLP Compliance Monitoring Program and the 

registrant of the outcome.

We found that, from fiscal year 2008 to fiscal year 2012, OECA GLP 

inspectors referred for reexamination the inspection results from 26 

laboratories and 73 studies to OPP. Table 2 lists the action taken by OPP 

as a result of its reexamination of studies, as of March 2014.

Table 2: Actions by EPA’s Office of Pesticide Programs Based on Good Laboratory 

Practices (GLP) Inspection Results, Fiscal Year 2008 to Fiscal Year 2012

Action

Number of 

Studies

Requested study be repeated 26

Rejected study and sponsor voluntarily cancelled or voluntarily 

suspended registration 4

No action needed 20

Review of study still pending 23

Total 73

Source: GAO analysis of EPA data.

Our analysis of EPA data shows that this review process, from the initial 

OECA GLP inspection to completion of OPP’s reexamination, takes on 

average about 2 years (see table 3).

Table 3: Average Time from EPA’s Office of Compliance and Assurance’s (OECA) Good Laboratory Practices (GLP) 

Inspection of Laboratory to EPA’s Office of Pesticide Program’s (OPP) Review of Inspection’s Impact on Laboratory’s Study, 

Fiscal Year 2008 to Fiscal Year 2012 

Average days

Average 

months

Completed reviews 

(of 50 studies)

a

Average time from start date of OECA’s GLP inspection of a laboratory to 

referral of inspection results to OPP 352 11 

Average time from date OECA referred inspection results to OPP to when 

OPP completed its review of inspection results’ impact on laboratory’s study 446 14

Average time from start date of OECA’s inspection to date OPP completed 

review of study 798 26 

Reviews still pending

(of 23 studies)

For those reviews that are still pending, average time from date of OECA 

GLP inspection to March 24, 2014 1066 34 

Source: GAO analysis of EPA data.

Note: Totals may not sum due to rounding. a

According to OPP officials, OPP has not denied a pesticide registration or 

revoked any registrations based on OECA laboratory inspection 

Average months were determined by dividing the average days by 31.
Page 26 GAO-14-289 Good Laboratory Practices

information during the past 5 years, but OPP has taken other actions 

because of that information, such as requiring a registrant to repeat a 

study or requesting that a registrant voluntarily cancel its registration. For 

example, according to data provided by an OPP official, in fiscal year 

2012, 15 studies associated with an already registered pesticide product 

were found to be “unacceptable” based on OECA inspection information. 

For 10 of these studies, EPA informed the registrants that they needed to 

repeat the study. For the 5 others, the registrant voluntarily canceled or 

suspended its registration associated with the study, or the study was not 

a deciding factor in the products registration and therefore EPA took no 

further action. In addition, OPP has required that an efficacy claim be 

removed from the label of a registered product based on a study 

submitted by a laboratory not meeting GLP standards.

OPP officials explained that a single study is not likely to affect the denial 

or approval of a pesticide registration because OPP usually bases its 

registration decisions on more than one study (although OPP officials 

noted their decision depends on, among other things, the type of study).

For example, according to OPP officials, some pesticides are the subject 

of more than 30 different studies before a decision is made on 

registration. However, these same officials stated that OPP believes that 

the GLP inspections are valuable not only to alert OPP to issues with 

study data and laboratories but to act as a deterrent to guard against the 

improper conduct of studies and submission of fraudulent or incorrect 

study data. According to OECA officials, GLP inspections often lead to 

positive action being taken by laboratories and pesticide registrants. They 

said that registrants have voluntarily withdrawn studies from OPP as a 

direct result of inspection notifications and inspection findings.
Page 27 GAO-14-289 Good Laboratory Practices

EPA and FDA do not regularly collaborate on GLP inspections and may 

be duplicating each other’s work by inspecting the same laboratories.42 In 

1984, EPA and FDA entered into an interagency agreement to 

collaborate on GLP inspections that was last renewed in 2004. Under the 

agreement, the two agencies agreed to collaborate in monitoring testing 

laboratories’ adherence to GLP regulations, as well as in auditing of 

health-related toxicological test reports and related laboratory records. 

The agencies also agreed to exchange information and coordinate 

actions concerning active investigations, regulation correspondence, and 

legal or administrative action being considered against any laboratory 

covered under the agreement. Among FDA’s responsibilities under the 

agreement was to conduct a certain number of on-site inspections of 

laboratories identified by EPA. From 2000 to 2007, FDA conducted a total 

of nine inspections identified by EPA (three in 2000; three in 2001; and 

one each in 2002, 2005, and 2007).43 EPA officials said they also formally 

met with FDA officials on a quarterly and annual basis to discuss 

upcoming inspections, but that communication ended by 2007 when, 

according to EPA officials, FDA began selecting laboratories for 

inspection on an annual basis instead of on a quarterly basis as EPA 

does. FDA also shifted from having its Office of Regulatory Affairs select 

laboratories for inspection to a more decentralized system, whereby its 

centers select laboratories for inspection, which made it more difficult for 

EPA to learn which laboratories FDA plans to inspect because it has to 

coordinate with multiple centers instead of the Office of Regulatory 

Affairs, according to EPA officials.44

 42We have defined duplication as occurring when two or more agencies or programs 

engaged in the same activities or provided the same services to the same beneficiaries.

EPA officials also said the last year 

FDA sent EPA a list of laboratories it planned to inspect was in 2007. 

They explained that, in the past, when EPA knew which laboratories FDA 

was going to inspect, it would ask FDA to audit a study for them and 

would avoid going to the same laboratory in the same year as FDA. 

However, since these meetings ended, EPA officials said that they do not 

always know if a laboratory was already inspected by FDA until they 

43FDA continued to perform inspections for EPA until 2007, although the agreement was 

not renewed after 2004.

44FDA consists of nine centers and offices. According to FDA officials, five of these 

centers conduct GLP inspections: the Center for Biologics Evaluation and Research, the 

Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, 

the Center for Food Safety and Applied Nutrition, and the Center for Veterinary Medicine.

EPA and FDA Do Not 

Regularly Collaborate 

on Laboratory 

Inspections and May 

Be Duplicating Each 

Other’s Work
Page 28 GAO-14-289 Good Laboratory Practices

arrive on-site. If EPA knew in advance that a laboratory was inspected by 

FDA recently, EPA inspectors could use FDA’s inspection results to 

inform their decision regarding whether conducting their own inspection 

was necessary. If FDA’s inspection results were sufficient for EPA’s 

purposes, EPA inspectors could potentially select a different laboratory to 

inspect in place of the one recently inspected by FDA, thereby extending 

limited resources. It is important to note, however, that, in some 

circumstances, it may be necessary for both agencies to inspect the 

same laboratory.

EPA officials stated that they occasionally coordinate with one of FDA’s 

centers on GLP inspections and stated that the two agencies performed a 

joint GLP inspection in 2013. In addition, EPA and FDA officials also said 

that both agencies participate in an FDA-led work group focusing on the 

modernization of laboratories. Officials from both agencies said that it 

would be useful to know which laboratories the other agency was 

planning to inspect and to have the results from those inspections. Since 

each agency only inspects a certain number of laboratories each year, 

sharing such information could help both agencies leverage resources. 

This coordination also could increase the number of laboratories that are 

inspected for GLP compliance, which in turn would help ensure that the 

study data submitted for pesticide registrations were generated in 

accordance with GLP regulations. However, the agencies do not regularly 

collaborate on or communicate about future inspections or share results 

from completed inspections.

FDA conducts two types of laboratory inspections, surveillance 

inspections, which are periodic, routine determinations of a laboratory’s 

compliance with GLP regulations and include a facility inspection and 

study audit, and directed inspections, which are inspections assigned to 

achieve a specific purpose, such as verifying the reliability, integrity, and 

compliance of critical safety studies. Because the two agencies do not 

regularly share GLP inspection-related information, we found that EPA 

and FDA may be duplicating each other’s work in some of their GLP 

inspections. For fiscal year 2005 to fiscal year 2012, EPA and FDA 
Page 29 GAO-14-289 Good Laboratory Practices

conducted a total of 170 GLP inspections of the same 37 laboratories.45

We also found that there is some degree of overlap in the laboratories 

that are eligible for inspection by the two agencies.

In 38 of the 170 inspections, the agencies inspected the same laboratory 

during the same fiscal year (see app. III.). For example, EPA inspected a 

Colorado laboratory in November 2011, and FDA conducted a 

surveillance inspection of this same laboratory 7 months later in June 

2012. Similarly, although EPA inspected a Utah laboratory in January 

2012, FDA conducted a surveillance inspection of this same laboratory 5 

months later, in June 2012. According to EPA and FDA officials, the GLP 

standards of the two agencies upon which these inspections are based 

are largely similar. Moreover, a senior official in OECA’s GLP Compliance 

Monitoring Program and representatives from three laboratories that were 

inspected by both EPA and FDA told us that the inspections were 

comparable.

46

 45EPA officials provided us with an analysis that identified GLP inspections conducted by 

EPA and FDA at 31 laboratories. We compared these 31 laboratories with our analysis 

that identified 37 laboratories. We found that EPA’s analysis included some additional 

laboratories that we could not find in our analysis. Conversely, EPA’s analysis excluded 

some laboratories that were included in our analysis, which was based on a review of 

inspection data provided to us by EPA and FDA.

Some laboratories 

covered by GLP regulations conduct tests yielding data that will be 

submitted to only EPA, but we found that other laboratories conduct tests 

for review by both EPA and FDA and are, therefore, eligible for inspection 

by both agencies. FDA officials told us that they did not have data to 

identify the total number of laboratories that submit data to both agencies 

and would, therefore, be subject to GLP inspections by both agencies. 

EPA officials and stakeholders we interviewed, however, told us that 

laboratories that conduct toxicology testing are the most likely to perform 

tests that are submitted to both EPA and FDA. For example, one 

representative from a laboratory in Maryland that had been inspected by 

both EPA and FDA eight times from fiscal year 2005 to fiscal year 2012 

told us that some of the information in the laboratory’s toxicology studies 

FDA officials examined during a 2011 GLP inspection could have been 

shared with EPA officials. In addition, in our survey, 5 of 19 respondents 

indicated that their facility conducted tests or studies intended for review 

by both EPA and FDA. FDA officials told us that there has been no recent 

46We have defined overlap as two or more agencies or programs engaging in similar 

activities or providing similar services to similar beneficiaries.
Page 30 GAO-14-289 Good Laboratory Practices

communication between the two agencies on which laboratories they plan 

to inspect and what they may have found at inspections that were 

conducted, although they have communicated this information in the past. 

FDA officials said they would welcome a list of inspections planned and 

conducted by EPA.

EPA and FDA officials said that, at present, they do not share the results 

of completed inspections at facilities that do both EPA and FDA-related 

studies, and they do not have a process in place to collaborate on future 

GLP inspections. As a result, EPA is not learning about laboratories that 

FDA has inspected and at which it may have found deficiencies. Similarly, 

FDA is not learning about the results of EPA laboratory inspections. In 

addition to potentially duplicating each others’ work, by not collaborating, 

the two agencies are missing opportunities to leverage each other’s 

resources and expand their inspection coverage. FDA officials told us it 

would be helpful to know if EPA had inspected a laboratory and that it 

would be particularly useful if EPA shared information if the agency had 

found problems during its inspection. EPA officials also said collaborating 

and communicating on inspections would be helpful.

In April 2013, we concluded that when executive branch agencies carry 

out activities in a fragmented and uncoordinated way, the resulting 

patchwork of programs can waste scarce funds, confuse and frustrate 

program customers, and limit the overall effectiveness of the federal 

effort.47 The federal government uses a range of mechanisms to 

implement interagency collaboration, such as interagency groups, and 

interagency agreements and memorandums of understanding.48 Key 

practices state that agencies that articulate their agreements in formal 

documents can strengthen their commitment to working collaboratively.49

 47GAO, 2013 Annual Report: Actions Needed to Reduce Fragmentation, Overlap, and 

Duplication and Achieve Financial Benefits, 

Written agreements are most effective when they are regularly updated 

and monitored. As we concluded in April 2013, where federal programs or 

activities are fragmented, overlapping, or duplicative, there are 

GAO-13-279SP (Washington, D.C.: April 

2013).

48GAO, Managing for Results: Key Considerations for Implementing Interagency 

Collaborative Mechanisms, GAO-12-1022 (Washington, D.C.: Sept. 27, 2012).

49GAO, Results-Oriented Government: Practices That Can Help Enhance and Sustain 

Collaboration among Federal Agencies, GAO-06-15 (Washington, D.C.: Oct. 21, 2005).
Page 31 GAO-14-289 Good Laboratory Practices

opportunities for agencies to improve the efficiency and effectiveness of 

government programs and activities.

50 Moreover, without leveraging its 

inspection resources with FDA, EPA may continue to have difficulty 

increasing annual GLP inspections of laboratories.

OECA has taken some steps to increase the number of GLP compliance 

inspections of laboratories conducting studies submitted to EPA for 

pesticide registration. However, OECA officials acknowledge that their 

four inspectors cannot inspect all 1,400 eligible laboratories for GLP 

compliance every 2 years, a time frame used by many of the countries 

that are members of OECD’s MAD agreement. Because some 

laboratories have never had a GLP inspection, laboratory and industry 

representatives expressed concern that if OECA continues to inspect so 

few laboratories for GLP compliance, U.S. laboratories and

manufacturers will be less competitive with foreign laboratories and 

manufacturers. In addition, with so many laboratories going uninspected, 

EPA may not have full assurance of the quality and integrity of data used 

to make pesticide registration decisions.

OECA officials told us that they have informally discussed the possibility 

of instituting user fees for the GLP program, but EPA has not conducted a 

formal evaluation of GLP user fees as directed by OMB guidance for 

programs not currently funded by such fees and, as recommended by 

EPA’s OIG. OECA might be able to increase the number of inspections it 

conducts if it were to charge a fee, which may be used to fund GLP 

inspections, as FDA does, and as do 17 European countries. Without 

assessing its authority and need for user fees, EPA cannot determine 

whether fees could make the laboratory inspection program selfsustaining. In addition, we found that the information in EPA databases

used by OECA to set priorities for laboratory inspection is sometimes 

incomplete or inaccurate. In the absence of reliable data, EPA may not 

have the data it needs to prioritize laboratories to inspect efficiently or 

effectively.

We commend OECA and OPP staff for communicating with each other on 

GLP inspection matters, including OECA consideration of OPP’s recent 

steps to identify laboratories that OPP considers to be priorities for GLP 

 50GAO-13-279SP.

Conclusions
Page 32 GAO-14-289 Good Laboratory Practices

inspections. Considering OPP’s request is important because most OECA 

inspections currently take place after OPP has made its registration 

decisions. However, EPA does not have documented procedures that 

define the responsibilities of each office in coordinating and prioritizing 

laboratories for GLP inspections consistent with federal standards of 

internal control. Without such procedures, there is no assurance that the 

two offices will consistently coordinate on GLP inspections in the future.

Furthermore, because EPA and FDA do not regularly share inspectionrelated information, as they did when they had an agreement to 

collaborate on GLP inspections, the agencies have inspected some of the 

same laboratories since 2007, while other laboratories may have gone 

without needed inspections. Without collaboration and informationsharing on planned and completed GLP inspections, EPA and FDA may 

duplicate GLP inspections, and EPA will have difficulty efficiently using its 

limited resources to increase the number of inspections it conducts. 

Officials from both agencies said that collaborating and communicating on 

inspections would be helpful. However, absent a formal written 

agreement, it is not clear that the agencies would regularly collaborate on 

future planned inspections and share results from completed inspections.

We are making four recommendations in this report.

To improve the OECA GLP inspection process, we recommend that the 

EPA Administrator take the following three steps:

1. Assess the authority and need for a fee-based inspection system, and 

if such a system is warranted, establish a user fee system, seeking 

additional legislative authority, if necessary, to make the laboratory 

inspection program self-sustaining.

2. Direct OECA and OPP to ascertain the exact causes of inaccurate 

and incomplete data in its databases and take action to ensure that 

the data, such as identification of performing laboratories and 

inspection history, are accurately recorded.

3. Direct OECA and OPP to develop documented procedures to 

coordinate and prioritize laboratories for inspections.

In addition, we recommend that the EPA Administrator and the FDA 

Commissioner develop a formal written agreement, such as a 

memorandum of understanding, that outlines how the two agencies plan 

to regularly collaborate and share information on GLP inspections and 

Recommendations for 

Executive Action
Page 33 GAO-14-289 Good Laboratory Practices

avoid duplication of inspections so that EPA can more efficiently use its 

limited resources.

We provided EPA and HHS with a draft of this report for their review and 

comment; EPA provided written comments, which are reproduced in 

appendix IV, and HHS provided written comments, which are reproduced 

in appendix V. 

In its written comments, EPA stated that it agreed with our findings,

conclusions, and all four of our recommendations. In response to our first 

three recommendations, EPA agreed 

• to assess the authority and need for a fee-based GLP inspection 

system;

• to ascertain the exact causes of inaccurate and incomplete data 

and ensure that the data are accurately recorded; and, 

• that OECA and OPP should develop written procedures to 

coordinate and prioritize GLP inspections. 

In response to our fourth recommendation, EPA agreed to develop written 

procedures that outline how EPA and FDA will collaborate and share 

information on GLP inspections. EPA stated that it did not agree that a 

formal memorandum of understanding between the two agencies was 

necessary. Our recommendation did not prescribe the type of agreement 

the agencies should undertake and offered a memorandum of 

understanding as one example. We agree that written procedures 

developed and agreed to by both EPA and FDA will address the

recommendation. 

In its technical comments, EPA noted that, while EPA and FDA have 

similar GLP regulations, and in a small number of cases both agencies 

may inspect the same laboratory, EPA does not believe the work is 

duplicative. However, we define duplication in this report as occurring 

when two or more agencies or programs engaged in the same activities 

or provided the same services to the same beneficiaries. We continue to 

believe that there is a possibility of duplication when both EPA and FDA 

are inspecting the same laboratories within a short period of time because 

both agencies provide a similar service to the same beneficiaries 

(ensuring laboratory compliance with GLP through facility inspections and 

study audits). Also in its technical comments, EPA acknowledged the 

problems we found with the databases used for targeting GLP inspections 

but stated that it does not believe these problems negatively affect 

Agency Comments 

and Our Evaluation
Page 34 GAO-14-289 Good Laboratory Practices

targeting for inspection because OECA is able to gather the necessary 

information manually. While we agree that, ultimately, EPA may target the 

appropriate laboratories for inspection through its manual research when 

the databases are inaccurate or incomplete, we believe that the agency’s 

reliance on manual research is not as efficient or effective as using 

databases containing accurate information.

In its written comments, HHS also agreed with our fourth 

recommendation. HHS also reiterated the point that there are legitimate 

reasons why GLP inspections may be conducted by both EPA and FDA

at a single laboratory within a relatively short period of time. For example, 

when FDA observes significant violations during for cause or surveillance 

inspections, follow-up inspections may be required to verify corrective 

actions. HHS also provided technical comments on our report, which we 

incorporated as appropriate.

As agreed with your office, unless you publicly announce the contents of 

this report earlier, we plan no further distribution until 30 days from the 

report date. At that time we will send copies to the EPA Administrator and 

the FDA Commissioner, the appropriate congressional committees, and 

other interested parties. In addition, the report will be available at no 

charge on the GAO website at http://www.gao.gov.

If you or your staff members have any questions about this report, please 

contact me at (202) 512-3841 or neumannj@gao.gov. Contact points for 

our Offices of Congressional Relations and Public Affairs may be found 

on the last page of this report. GAO staff who made key contributions to 

this report are listed in appendix VI.

Sincerely yours,

John Neumann

Acting Director, Natural Resources and Environment
Appendix I: Objectives, Scope and 

Methodology

Page 35 GAO-14-289 Good Laboratory Practices

Our objectives were to examine the extent to which (1) the Environmental 

Protection Agency (EPA) inspects for GLP compliance laboratories that 

test pesticides and the challenges, if any, EPA faces in doing so, (2) EPA 

uses the information obtained through Good Laboratory Practices (GLP) 

laboratory inspections in its pesticide decision-making process, and (3) 

EPA and the U.S Food and Drug Administration (FDA) collaborate on 

GLP inspections. To address these objectives, we reviewed relevant 

federal statutes and regulations,1 EPA program and guidance 

documents,2 federal internal control standards,3 Office of Management 

and Budget circulars4

, and previous GAO and EPA Inspector General 

reports.5

 1

These statutes and regulations include Federal Insecticide, Fungicide, and Rodenticide 

Act, Act of June 25, 1947, ch. 125, 61 Stat. 163 (codified as amended at 7 U.S.C. §§ 136-

136y); Federal, Food, Drug, and Cosmetic Act, Act of June 25, 1938, ch. 675, 52 Stat. 

1040 (codified as amended at 21 U.S.C. §§ 301-399f); 21 C.F.R. pt. 58; 40 C.F.R. pts. 

152-180.

We also reviewed EPA’s fiscal year 2011-2015 strategic plan; 

EPA’s fiscal year 2011, 2012, and 2013 annual agency financial reports; 

and EPA Office of Enforcement and Compliance Assurance (OECA) 

fiscal year 2012 Budget Adjustment Plan. In addition, we interviewed 

EPA’s Office of Pesticide Programs (OPP) and OECA officials and 

reviewed documentation they provided to obtain further information and 

clarification on EPA’s pesticide registration process and how it relates to 

the GLP process, and we interviewed FDA officials and reviewed 

documentation they provided on FDA’s GLP process. Furthermore, we 

reviewed recent literature related to GLP, including information and 

documents found on the websites of a variety of industry, international, 

environment, and academia organizations, and foreign government GLP 

inspection programs. We interviewed about 25 representatives from these 

organizations. We selected these individuals based on referrals from 

EPA, and industry and environmental stakeholders.

2

These program and guidance documents included EPA, Good Laboratory Practice 

Standards, Inspection Manual, (Washington, D.C.: Sept. 1993); Enforcement Response 

Policy for the Federal Insecticide, Fungicide, and Rodenticide Act, Good Laboratory 

Practices (GLP) Regulations, Sept. 1991. 

3

GAO/AIMD-00-21.3.1.

4

Office of Mgmt. & Budget, Circular No. A-25 Revised, Memorandum for Heads of 

Executive Departments and Establishments (July 8, 1993).

5 GAO-06-15; EPA Office of Inspector General, EPA Did Not Conduct Thorough Biennial 

User Fee Reviews, 14-P-0129 (Washington, D.C.: Mar. 4, 2014).

Appendix I: Objectives, Scope and 

Methodology
Appendix I: Objectives, Scope and 

Methodology

Page 36 GAO-14-289 Good Laboratory Practices

To examine to what extent EPA inspects for GLP compliance laboratories 

that test pesticides; and the challenges, if any, EPA faces in doing so, we 

collected and analyzed documentation from OECA officials on its GLP 

inspection process and analyzed EPA laboratory and inspection data, the 

agency’s use of this data , and the accuracy and completeness of the 

data. Specifically, we obtained information on how OECA determines 

which laboratories to inspect and how EPA’s Office of Pesticide Programs 

Information Network (OPPIN), Laboratory Information and Study Audit 

(LISA), and Integrated Compliance Information System (ICIS) databases 

are used to assist inspectors in making these decisions, as well as the 

type of inspection data that are entered into these databases. Regarding 

inspection data, we requested OECA to provide us with several data 

elements contained in its LISA database for the years 2000 to 2013, 

including name and location of laboratory inspected, reason for 

inspection, number and type of inspections conducted, and number and 

name of studies associated with the laboratory inspected. We determined 

that inspection data were sufficiently reliable to present results on the 

number of inspections from fiscal year 2009 to fiscal year 2013 as a 

range. Since data, such as laboratories names and addresses, as well as 

information on studies contained in OECA’s LISA database are 

transferred from OPP’s OPPIN, we also requested OPP provide 

information from OPPIN on the number of studies associated with 

performing GLP laboratories from fiscal year 2008 to fiscal year 2012. We 

analyzed this study data for accuracy and completeness. However, we 

determined that data for “performing laboratories,” identification numbers, 

and addresses were not sufficiently reliable to assess the number and 

location of laboratories that had submitted studies to EPA. As a result, we 

were not able to define the universe of laboratories subject to a GLP 

inspection. However, EPA did provide estimates of the number and 

percentage of eligible laboratories that were inspected each year, and we 

used that information in this report.

To determine the views on EPA’s GLP Compliance Monitoring Program, 

we interviewed individuals representing 25 entities, including laboratories, 

pesticide manufacturers, international organizations, environmental and 

health organizations, national and trade associations and foreign 

government GLP programs, which we selected based on referrals from 

various stakeholders and EPA officials. Specifically, we spoke with 

representatives of nine laboratories and conducted site visits to four of 

these laboratories located in Maryland and Illinois. We also conducted a 

Web-based survey of performing laboratories. For our survey, we drew a 

randomly selected sample of 80 performing laboratories included in the 

OPPIN database that sent study data to OPP from fiscal year 2010 to 
Appendix I: Objectives, Scope and 

Methodology

Page 37 GAO-14-289 Good Laboratory Practices

fiscal year 2012. Because OPPIN does not contain e-mail addresses, we 

searched for laboratories’ e-mail addresses and found them for 53 of the 

80 laboratories that we sampled. We sent the Web-based survey to these 

53 laboratories. We obtained responses from 26 laboratories and other 

entities. However, 6 of these 26 respondents stated that they were not a 

laboratory and did not conduct GLP testing. Therefore, we received 

usable survey responses from 20 laboratories. Not all respondents to our 

survey, however, answered every question. Our survey asked if the 

laboratory had conducted GLP testing for EPA or FDA, experienced a 

GLP inspection by EPA, what was the effect of having an inspection, and 

what improvements they thought could be made to EPA’s GLP Inspection 

Monitoring Program. The survey results are not generalizeable to all 

laboratories that are covered by the GLP program, but they were 

randomly selected, and the results can provide examples of such 

laboratories’ experiences and challenges with GLP inspections. We were 

not able to select a representative sample because some data in the

OPPIN database was not sufficiently reliable.

To assess the extent to which OPP uses the information obtained through 

GLP laboratory inspections in its pesticide decision-making process, we 

analyzed relevant documents and databases to determine the number of 

OECA’s GLP inspections that produced results that were referred to OPP 

for reexamination, the time it took to conduct these reexaminations, and 

any impact the inspections had on OPP’s pesticide registration decisions.

To determine the extent to which EPA and FDA collaborate on 

inspections, we analyzed EPA and FDA GLP laboratory inspection data 

and determined that the inspection data were sufficiently reliable for our 

purposes. We also analyzed the 20 laboratory survey responses to 

determine if they had conducted GLP tests or studies for submission to 

both EPA and FDA since 2008. We reviewed agency documents, such as 

a 1984 agreement entered into by EPA and FDA to cooperate on GLP 

inspections and FDA’s Compliance Program Guidance Manual. We 

interviewed EPA and FDA officials, laboratory representatives and other 

stakeholders about the potential for the two agencies to collaborate.

We conducted this performance audit from November 2012 to May 2014 

in accordance with generally accepted government auditing standards. 

Those standards require that we plan and perform the audit to obtain 

sufficient, appropriate evidence to provide a reasonable basis for our 

findings and conclusions based on our audit objectives. We believe that 

the evidence obtained provides a reasonable basis for our findings and 

conclusions based on our audit objectives.
Appendix II: Web-Based Survey to 

Laboratories

Page 38 GAO-14-289 Good Laboratory Practices

Appendix II: Web-Based Survey to 

Laboratories
Appendix II: Web-Based Survey to 

Laboratories

Page 39 GAO-14-289 Good Laboratory Practices
Appendix II: Web-Based Survey to 

Laboratories

Page 40 GAO-14-289 Good Laboratory Practices
Appendix III: Laboratories Inspected for GLP 

Compliance by EPA and FDA, FY 2005-2012

Page 41 GAO-14-289 Good Laboratory Practices

Our analysis of Environmental Protection Agency (EPA) and U.S. Food 

and Drug Administration (FDA) Good Laboratory Practices (GLP) 

inspections data identified the following instances where laboratories 

were inspected by both agencies (see figure 3). We do not know the 

reason for every inspection. In some instances, EPA and FDA may have 

needed to conduct their own inspection.

Appendix III: Laboratories Inspected for GLP 

Compliance by EPA and FDA, FY 2005-2012
Appendix III: Laboratories Inspected for GLP 

Compliance by EPA and FDA, FY 2005-2012

Page 42 GAO-14-289 Good Laboratory Practices

Figure 3: Laboratories Inspected for GLP Compliance by EPA and FDA, FY 2005-2012
Appendix III: Laboratories Inspected for GLP 

Compliance by EPA and FDA, FY 2005-2012

Page 43 GAO-14-289 Good Laboratory Practices

(Continued)
Appendix III: Laboratories Inspected for GLP 

Compliance by EPA and FDA, FY 2005-2012

Page 44 GAO-14-289 Good Laboratory Practices

(Continued)
Appendix III: Laboratories Inspected for GLP 

Compliance by EPA and FDA, FY 2005-2012

Page 45 GAO-14-289 Good Laboratory Practices

(Continued)
Appendix III: Laboratories Inspected for GLP 

Compliance by EPA and FDA, FY 2005-2012

Page 46 GAO-14-289 Good Laboratory Practices

(Continued)
Appendix III: Laboratories Inspected for GLP 

Compliance by EPA and FDA, FY 2005-2012

Page 47 GAO-14-289 Good Laboratory Practices

(Continued)
Appendix IV: Comments from the 

Environmental Protection Agency

Page 48 GAO-14-289 Good Laboratory Practices

Appendix IV: Comments from the 

Environmental Protection Agency
Appendix IV: Comments from the 

Environmental Protection Agency

Page 49 GAO-14-289 Good Laboratory Practices
Appendix V: Comments from the Department 

of Health and Human Services

Page 50 GAO-14-289 Good Laboratory Practices

Appendix V: Comments from the Department 

of Health and Human Services 
Appendix V: Comments from the Department 

of Health and Human Services

Page 51 GAO-14-289 Good Laboratory Practices
Appendix VI: GAO Contact and Staff 

Acknowledgments

Page 52 GAO-14-289 Good Laboratory Practices

John Neumann, (202) 512-3841 or neumannj@gao.gov

In addition to the individual named above, Anne K. Johnson, Assistant 

Director; Cheryl Arvidson; Mark Braza; Greg Carroll; Cynthia Grant; 

Angela Miles; and Patricia Moye made key contributions to this report. 

Richard Johnson, Stuart Kaufmann, Anna Maria Ortiz, and Dan Royer 

also made important contributions.

Appendix VI: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments

(361449)
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